Insulin Lispro Recombinant

For diabetes mellitus. Sold as Humalog, Humalog Tempo. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 2 applications for Insulin Lispro Recombinant (sold as Humalog, Humalog Tempo), first approved Jun 14, 1996, with 8 new uses approved and 0 published complete response letters.

First approved: Jun 14, 1996
Applications: 2
New uses approved: 8
Complete response letters: 0

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

HUMALOG 100 UNIT/ML CARTRIDGE: $9.79 per MLBrand · +0% in a year
HUMALOG 100 UNIT/ML KWIKPEN: $10.16 per MLBrand · 0% in a year
HUMALOG 100 UNIT/ML VIAL: $6.36 per MLBrand · +0% in a year
HUMALOG 200 UNIT/ML KWIKPEN: $20.31 per MLBrand · -70% in a year

Shortages

FDA's drug shortage list, as of Nov 13, 2026

Shortage	Status	First posted	Updated
Insulin Lispro Injection	To Be Discontinued	Sep 1, 2026	Sep 1, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Jun 14, 1996	Humalog, Humalog TempoBLA 20563 · New molecular entity	Lilly	84	Marketed
May 26, 2015	HumalogBLA 205747 · New formulation or manufacturer	Eli Lilly And Co	11	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA